OLYMPUS TELESCOPE A22002A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-10-08 for OLYMPUS TELESCOPE A22002A manufactured by Olympus Winter & Ibe Gmbh.

Event Text Entries

[1695340] The user facility reported that during a therapeutic transurethral resection of bladder tumor (turbt) procedure, the users experienced a complete loss of image. The user facility reported that when the first telescope was introduced to the pt, and when the user pressed the foot switch of the electrosurgical unit, the user observed a visual arcing, heard two "poofs", and reportedly smelt an electrical burn; however, the user did not specify the source. The user subsequently reported that they could no longer see anything through the telescope. The user withdraw the first telescope and used a second telescope. Upon insertion of the second telescope it blew out, the telescope was then withdrawn from the pt, and a third telescope was used and this time the users replaced the working element, bovie cord. Upon introduction of the third telescope to the pt, the third telescope blew out. The first three attempts were reportedly performed by a resident. Finally, the attending physician replaced all the equipment in the system except for the electrosurgical unit and the light source, and completed the procedure without any adverse impact to the pt.
Patient Sequence No: 1, Text Type: D, B5


[8691268] Olympus followed up with the user facility via telephone and in writing to obtain additional and clarifying information regarding the report, as there was conflicting information provided regarding the report; however, no further information was provided. The telescope referenced in this report was returned to olympus with the complaint of blurry image. The evaluation confirmed the users report of image difficulty due to broken lens inside the optical fiber system. In addition, the outer tube was found bent, which likely caused the image difficulty. The bent outer tube is attributed to physical damage due to mishandling. The concomitant devices were not returned to olympus for evaluation. If additional significant information will become available later, this report will be supplemented. This report is being submitted as a medical device report in an abundance of caution. Olympus america inc is filing mdrs (b)(4). Cross-referenced mfr. Report number 9610773-2010-00034, and 9610776-2010-00036 for the associated device.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9610773-2010-00035
MDR Report Key1867410
Report Source06
Date Received2010-10-08
Date of Report2010-09-09
Date of Event2010-09-09
Date Mfgr Received2010-09-09
Date Added to Maude2010-11-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactLAURA STORMS-TYLER
Manufacturer Street2400 RINGWOOD AVE
Manufacturer CitySAN JOSE CA 95131
Manufacturer CountryUS
Manufacturer Postal95131
Manufacturer Phone4848965688
Manufacturer G1OLYMPUS WINTER & IBE GMBH
Manufacturer StreetKUEHNSTRASSE 61
Manufacturer CityHAMBURG 22045
Manufacturer CountryGM
Manufacturer Postal Code22045
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOLYMPUS TELESCOPE
Generic NameTELESCOPE
Product CodeFBP
Date Received2010-10-08
Returned To Mfg2010-09-17
Model NumberA22002A
Lot NumberNA
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS WINTER & IBE GMBH
Manufacturer AddressKUEHNSTRASSE 61 HAMBURG 22045 GM 22045


Patients

Patient NumberTreatmentOutcomeDate
10 2010-10-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.